EP0462606A1 - Procédé et appareillage pour la production de solutions aqueuses stériles - Google Patents

Procédé et appareillage pour la production de solutions aqueuses stériles Download PDF

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Publication number
EP0462606A1
EP0462606A1 EP91110104A EP91110104A EP0462606A1 EP 0462606 A1 EP0462606 A1 EP 0462606A1 EP 91110104 A EP91110104 A EP 91110104A EP 91110104 A EP91110104 A EP 91110104A EP 0462606 A1 EP0462606 A1 EP 0462606A1
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EP
European Patent Office
Prior art keywords
water
reverse osmosis
sterile
injection
deionization
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP91110104A
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German (de)
English (en)
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EP0462606B1 (fr
Inventor
Anil D. Jha
Laura Lee Deming
Ralf Kuriyel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
EMD Millipore Corp
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Millipore Corp
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Publication date
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Publication of EP0462606A1 publication Critical patent/EP0462606A1/fr
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Publication of EP0462606B1 publication Critical patent/EP0462606B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/44Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis
    • C02F1/441Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis by reverse osmosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/022Filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/166Heating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/166Heating
    • A61M1/1662Heating with heat exchange between fresh and used dialysate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/1668Details of containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287Dialysates therefor
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/02Treatment of water, waste water, or sewage by heating
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/28Treatment of water, waste water, or sewage by sorption
    • C02F1/283Treatment of water, waste water, or sewage by sorption using coal, charred products, or inorganic mixtures containing them
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/42Treatment of water, waste water, or sewage by ion-exchange
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/44Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis
    • C02F1/444Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis by ultrafiltration or microfiltration
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2103/00Nature of the water, waste water, sewage or sludge to be treated
    • C02F2103/02Non-contaminated water, e.g. for industrial water supply
    • C02F2103/026Treating water for medical or cosmetic purposes
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F2303/00Specific treatment goals
    • C02F2303/04Disinfection

Definitions

  • This invention relates to a method and system for producing purified water, sterile water or a sterile aqueous solution for biological and medical uses. More particularly, this invention relates to a method and apparatus for producing sterile aqueous solutions meeting all user specifications including bacteriological specifications to permit their administration directly or indirectly to a patient.
  • sanitizing agents such as formalin or chlorine which control biologic contaminants. While these sanitizing agents perform their function well, they are highly toxic to humans, are difficult to handle and are difficult to rinse out of the purification system. The use of these chemicals has major adverse environmental impact as well.
  • a second method for insuring biologic purity of water treated with a membrane filter system is to treat the system with a second process which insures the control of all living organisms.
  • One such method is to heat the water with a pasteurization process.
  • components within the system such as certain reverse osmosis membranes cannot withstand pasturization temperatures. Therefore, when utilizing a system which is sanitized with high temperature water, undesirable by-pass loops and valves to reverse osmosis units are introduced. Therefore, this method does not clean and sanitize the reverse osmosis unit.
  • a third method is to pass the purified water through a filter that is capable of filtering from the water all biologically active material.
  • this process requires that the initial filtration treatment reduces the bacterial contamination to sufficiently low levels so that the bacterial removal filter does not clog prematurely. This is a very expensive proposition which renders it impractical. Therefore after initial filtration, chemical sanitization agents are still currently required to maintain low bacterial levels in the system.
  • British Patent Nos. 1,450,030 and 2,034,584 also disclose means for providing pyrogen free and bacteria free aqueous solution at the site of use of the solutions.
  • each of these systems relies upon the use of chemical disinfectant such as with formalin to sanitize the equipment or flash sterilization wherein the water used to form the aqueous solution is heated to a temperature, typically 150°C to 160°C.
  • chemical sanitization is undesirable even though it is an effective means for killing microorganisms because it also introduces harmful chemicals into the system which can be administered accidentally to the patient.
  • heat sterilization of the water used to form the aqueous solution is undesirable since sterilization is accomplished only in portions of the system exposed to the high temperature.
  • the bacteria and pyrogens continue to multiply in the remaining portion of the system thereby preventing the desired fluid quality from being produced.
  • U.S. Patent No. 4,610,790 discloses a system for forming USP XX grade water from tap water which includes a carbon-based filtration unit, a reverse osmosis unit, a deionization unit and an ultrafiltration unit.
  • the ultrafiltration unit and the deionization unit are flushed with heated water.
  • the reverse osmosis unit is flushed with unheated water and the carbon-based filtration unit is replaced periodically. Since the carbon-based filtration unit and reverse osmosis unit are not exposed to heated water, additional bypass loops and valves must be added to the system.
  • the non-sanitized filter units may eventually produce unacceptable quality product.
  • this system requires a redundant filtration unit for removal of bacteria and pyrogens because the reverse osmosis unit can not be heat sanitized.
  • a method and system are provided for producing water quality that meets AAMI water for dialysis standards, USP XXII water for injection and sterile water for injection specifications.
  • Potable water is passed through a preliminary filtration step, a carbon adsorption module and a reverse osmosis module to produce water quality that meets the AAMI water standard for dialysis.
  • an ion exchange filtration step is added to the system, if necessary, that produces AAMI water from water containing undesirably high salt concentration.
  • a disposable sterile microfilter is added as a final element for producing USP XXII grade water.
  • the system can be utilized to produce solutions such as peritoneal dialysis fluid, intravenous injection fluid and other medical use fluids.
  • the fluid production is accomplished by accurately metering a concentrated fluid into the high purity water produced by the system at a given ratio, e.g., a sodium chloride injection concentrate (twenty times concentrated) is mixed with USP XXII grade water for injection at the rate of nineteen parts water to one part concentrate and then passed through a disposable sterile microfilter to produce sterile sodium chloride injection solution.
  • the final solution can either be packaged in sterile intraveneous (IV) containers or used directly in medical applications.
  • peritoneal dialysis fluids can be produced by addition of concentrated peritoneal dialysis fluid to the AAMI standard water produced by the system and then passing the solution through a disposable sterile microfilter.
  • the final solution can either be packaged in sterile containers or administered directly into the abdominal cavity of the patient.
  • microbiological control in all of the systems described above is accomplished by periodic recirculation and/or flushing of high temperature water for a given period of time over all permanent wetted surfaces within the system including the preliminary filter, the carbon adsorption module, the reverse osmosis module and the ion exchange filtration module but excluding items that are replaced periodically such as the disposable sterile microfilter. If a semi-permanent sterile microfilter, such as ceramic microfilter, is utilized it can also be sanitized during the sanitization phase.
  • Figure 1 is a schematic diagram of the method and system of this invention for producing water which meets specifications of AAMI standard water for dialysis.
  • Figure 2 is a schematic diagram of the method and system of this invention for producing water quality that meets USP XXII specifications for water for injection quality water.
  • Figure 3 is a schematic diagram of the method and system of this invention including a sterile microfilter for producing water quality that meets USP XXII specifications for sterile water for injection quality water.
  • Figure 4 is a schematic diagram of the method and system of this invention for producing sterile peritoneal dialysis solution.
  • Figure 5 is a schematic diagram of the method and system of this invention for producing a sterile medical solution.
  • USP XXII grade sterile water for injection is produced by subjecting potable water to prefiltration, carbon adsorption, reverse osmosis, deionization and finally sterile microfiltration.
  • the USP XXII specifications for water injection are detailed in The United States Pharmacopeia Convention, Inc., XXII pages 1456 and 1457 dated January 1, 1990.
  • the specifications include allowable limits on heavy metals and other chemical (organic and inorganic) contaminants, pH and total dissolved solids.
  • the purified water must be sterile and non-pyrogenic.
  • the chemical impurities in the potable water are removed by the various filtration methods incorporated in the system.
  • the prefilter element removes particulate matter present in the water.
  • the carbon filter element satisfies the dual requirement of removing halogens as well as dissolved organics present in the incoming water.
  • the reverse osmosis element removes dissolved ionic impurities, certain organics and is also a barrier for bacteria and pyrogens present in the water.
  • the deionization element removes remaining trace ionic impurities in the purified water from the reverse osmosis module.
  • the sterile microfilter is a sterile barrier for any remaining bacteria in the system.
  • a novel method of periodic system sanitization preferably daily, is employed.
  • the sanitization is accomplished by circulating or flushing hot water through the system for a time temperature combination sufficient to effect system sanitization, but less than that at which degradation of material in a module occurs.
  • water at a temperature of about 80°C to 100°C can be circulated through the system for up to two hours.
  • the heated water is passed over all wetted surfaces in the system thereby limiting any bacteria growth during system operation and/or idle period.
  • the pyrogens generated during system operation, idle period and during sanitization are flushed away in the post sanitization flush of the system.
  • the reverse osmosis module continues as a barrier for bacteria and pyrogens.
  • the heated water kills the bacteria on the inlet side of the reverse osmosis module as well as any bacteria that may have passed through the reverse osmosis module.
  • the pyrogens are flushed away during the post sanitization flush from all sections of the system.
  • the disposable sterile microfilter is a barrier for any bacteria in the system and is always employed during operation but is disposed of prior to sanitization. The microfilter is changed periodically and therefore does not require sanitization. Certain microfilters such as ceramic microfilters may be semi-permanent and therefore may be sanitized along with other components.
  • the ability of the system to produce sterile water for injection is dependent on a combination of three major operating modes. They are: (1) Production of sterile water for injection (2) System sanitization and (3) System flush.
  • a typical operating method for operating the system comprises the production of sterile water for approximately twenty-two hours. Thereafter, the system is sanitized with heated water, such as at 80°C for two hours, followed by a system flush with cool water for about fifteen (15) minutes. After flushing, the system is ready to produce sterile water again in accordance with the described method.
  • the filters remove impurities as described above from the incoming potable water.
  • the prefilter element, carbon element and deionization element retain their respective impurities and at exhaustion of capacity, they are discarded.
  • the reverse osmosis element is a tangential flow device consisting of three separate streams; namely, feed, reject and product.
  • the water from the feed side sweeps across the surface of a semi-permeable membrane in the element and is discarded via the reject stream. A portion of the feed water passes through the membrane as purified water for further processing if necessary.
  • the microbial impurities from the feed water are retained and/or discarded via the reject stream.
  • a very minute quantity of microbiological contaminate may pass through the reverse osmosis element and contaminate the elements positioned downstream of the reverse osmosis element. These contaminants are then captured by the disposable sterile filter element located downstream. By this means, sterile water can be produced by the system.
  • the method involves sanitization of the total system at a temperature and time that will control microbial population to the desired level as required by the user requirements, for example, approximately 80°C or higher temperature for approximately two hours on a daily basis.
  • the recirculation and/or flushing of heated water through the system controls the bacteria present in the prefilter element, the carbon element, the inlet and outlet sides of the reverse osmosis element and any associated piping and accessories in the fluid path.
  • the system utilized in the present invention includes a water inlet 10 for potable tap water which is controlled by valve (V1) 12 and pressure regulator (PR) 14.
  • a heat exchanger (HE) 16 is provided to recover wasted heat exiting from the system.
  • the tap water is pumped by means of pump (M1) 20.
  • a bypass valve (V2) 18 is utilized for feed flow rate control to the reverse osmosis element.
  • the tap water is directed to heater (H) 22, which may be activated to maintain a desired operating temperature of the system.
  • the water is then passed through prefilter (PF) 24 and prefilter 24 is provided with differential pressure monitors ( ⁇ P) 23 which determine when the pressure across the prefilter exceeds a predetermined limit for filter changeout.
  • the water is then passed through an adsorption element (C) 26 containing temperature resistant ion exchange resin, activated carbon particles or mixtures thereof, the adsorption particles utilized in step 26 are capable of withstanding the heat of the water utilized to sanitize the system in a subsequent sanitization step.
  • Differential pressure monitors ( ⁇ P) 25 may be used to determine when the pressure across the element exceeds a predetermined standard pressure for change out.
  • the filtered water then is passed to reverse osmosis unit (RO) 28 containing a temperature resistant membrane capable of withstanding the heat of the water utilized in the subsequent sanitization step.
  • Conductivity monitors (C1), (C2), 27 and 29 monitor the performance of the reverse osmosis unit (RO) 28.
  • Conductivity monitor (C2) 29 also assures the quality of the water produced.
  • the reject conduit from reverse osmosis unit (RO) 28 passes through back pressure regulator V3 (33) which allows for adjustment of the product to reject ratio.
  • Valve (V4) 32 remains closed during operation and is left open during sanitization since minimal back pressure is desired for the operation of the reverse osmosis unit (RO) 28 at high sanitization temperatures.
  • the purified water is passed through valve (V5) 30 and then to be used as water for dialysis.
  • Valve (V6) 34 remains closed during normal operation.
  • the water from reject conduit side and valve (V6) 34 are combined at location 35 and passed through heat exchanger (HE) 16 to recover heat prior to passing to drain 36.
  • the heater (H) 22 then is deactivated at the completion of sanitization and the system is flushed of the heated water by means of incoming potable water.
  • An air break or a check valve (CV) 51 is included in the drain line to prevent any backflow of contaminated water into the product.
  • the system of Figure 2 includes an ion exchange module (IX) 37 if necessary, in order to render the system capable of producing water quality equivalent to or better then standards specified in USP XXII water for injection from water feed containing undesirably high salt concentration.
  • Conductivity monitors (C2) and (C3), 29 and 38 monitor the efficiency of the ion exchange module (IX) 37.
  • Conductivity monitor (C3) 38 also assures the quality of water produced.
  • the heater (H) 22 is activated as water passes through the reverse osmosis unit (RO) 28 as discussed in figure 1.
  • the water from the product side of the reverse osmosis unit (RO) 28 passes through the ion exchange module (IX) 37 and then through valve (V6) 34, combines with water from valve (V4) 32 and then is discarded via heat exchanger (HE) 16 through drain 36.
  • Valve (V5) 30 remains closed during sanitization. The system then is flushed in the manner set forth above.
  • the system of Figure 3 includes a sterile microfilter (MF) 39 which is disposed of after a cycle of producing sterile water for injection.
  • MF sterile microfilter
  • heater 22 is activated and hot water is circulated through the modules 24, 26, 28 and 37 and then through 34 to 16 to drain 36. Thereafter, the system is flushed out with water to elute the remaining pyrogens which are directed to drain 36.
  • a system for producing a solution containing a medicament such as peritoneal dialysis solution.
  • the system shown in Figure 4 is identical to the system shown in Figure 1 except that means for proportioning purified water and a concentrated medicament is provided. All of the other components function in the manner described above.
  • a concentrated peritoneal dialysis (medicament) solution is stored in container 44 and is dispensed via proportioning module 46 into admixture with the purified water from the reverse osmosis module (RO) 28. Thereafter, the proportioned solution is passed through sterile microfilter (MF) 39 for use.
  • MF sterile microfilter
  • the sanitization of the system is the same as shown in Figure 1 but, if desired, the container (CN) 44 and associated piping can be included in the high temperature sanitization loop to maintain control of bacteria and pyrogens. The system then is flushed in the manner set forth above.
  • FIG. 5 the elements of Figure 4 are included in the system which function in the manner described above with the addition of an ion exchange module (IX) 37.
  • the concentrated medical solution is stored in container (CN) 50, is dispensed via proportioning module 46 into admixture with the purified water from ion exchange module (IX) 37.
  • the resulting dilute medical solution is passed through sterile microfilter 39 for use.
  • the sanitization of the system is the same as shown in Figure 2 but, if desired, the container (CN) 50 and associated piping can be included in the high temperature sanitization loop to maintain control of bacteria and pyrogens.
  • the system then is flushed in the manner set forth above.
  • the adsorption step (C) 26 and reverse osmosis step (RO) 28 can be in any sequence. For example, if the incoming impure water contains no chlorine or if the reverse osmosis membrane is chlorine resistant, reverse osmosis step (RO) 28 can precede adsorption step (C) 26. However, the sterilizing microfilter (MF) 39 is always utilized downstream of the reverse osmosis and/or adsorption steps when producing sterile product.
  • MF sterilizing microfilter
EP91110104A 1990-06-20 1991-06-19 Procédé et appareillage pour la production de solutions aqueuses stériles Expired - Lifetime EP0462606B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/541,010 US5032265A (en) 1990-06-20 1990-06-20 Method and system for producing sterile aqueous solutions
US541010 1990-06-20

Publications (2)

Publication Number Publication Date
EP0462606A1 true EP0462606A1 (fr) 1991-12-27
EP0462606B1 EP0462606B1 (fr) 1995-09-20

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EP91110104A Expired - Lifetime EP0462606B1 (fr) 1990-06-20 1991-06-19 Procédé et appareillage pour la production de solutions aqueuses stériles

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US (1) US5032265A (fr)
EP (1) EP0462606B1 (fr)
DE (1) DE69113129T2 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0970919A1 (fr) * 1998-07-08 2000-01-12 Klaus Dr. Leiter Dispositif pour la désinfection d'une unité de traitement d'eau
WO2000057926A1 (fr) * 1999-03-30 2000-10-05 Hospal Industrie Procede et dispositif pour steriliser et dispenser un liquide a usage medical
WO2000057925A1 (fr) * 1999-03-30 2000-10-05 Hospal Industrie Procede et dispositif pour steriliser et dispenser un liquide a usage medical
WO2000057927A1 (fr) * 1999-03-30 2000-10-05 Hospal Industrie Procede et dispositif pour steriliser et dispenser un liquide a usage medical
US6579494B1 (en) 1999-03-30 2003-06-17 Hospal Industrie Process and device for sterilizing and dispensing a liquid for medical use
FR2845605A1 (fr) * 2002-10-15 2004-04-16 Gambro Lundia Ab Procede et dispositif pour la preparation en ligne de liquide pour un appareil destine au traitement extracorporel du sang
WO2004037726A1 (fr) * 2002-10-23 2004-05-06 Usfilter Corporation Production d'eau pour injection par osmose inverse
ES2237242A1 (es) * 2002-10-29 2005-07-16 Jesus Manuel Taboada Presedo Sistema de tratamiento de agua para hemodialisis.
US8585882B2 (en) 2007-11-30 2013-11-19 Siemens Water Technologies Llc Systems and methods for water treatment
US9023185B2 (en) 2006-06-22 2015-05-05 Evoqua Water Technologies Llc Low scale potential water treatment

Families Citing this family (107)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5242595A (en) * 1991-04-25 1993-09-07 U.S. Filter/Illinois Water Treatment, Inc. Bacteria removal by ceramic microfiltration
US5902476A (en) * 1991-08-21 1999-05-11 Twardowski; Zbylut J. Artificial kidney for frequent (daily) hemodialysis
US5259954A (en) * 1991-12-16 1993-11-09 Sepratech, Inc. Portable intravenous solution preparation apparatus and method
US5281344A (en) * 1992-01-23 1994-01-25 Pall Corporation Regenerable sorbent system
US5403489A (en) * 1993-06-24 1995-04-04 Minnesota Mining And Manufacturing Company Solid phase extraction method and apparatus
SE510026C2 (sv) * 1994-09-23 1999-04-12 Gambro Ab Desinficeringsanordning för dialysmaskin
US5591344A (en) * 1995-02-13 1997-01-07 Aksys, Ltd. Hot water disinfection of dialysis machines, including the extracorporeal circuit thereof
DE29623801U1 (de) * 1995-03-03 1999-11-11 Alltech Associates Inc Apparat zur elektrochemischen Modifizierung chromatographischen Materials
US5935443A (en) * 1995-03-03 1999-08-10 Alltech Associates, Inc. Electrochemically regenerated ion neutralization and concentration devices and systems
US6416676B1 (en) 1995-05-24 2002-07-09 National Semiconductor Corporation Deionized water degasification for semiconductor fabrication
US5647984A (en) * 1995-06-07 1997-07-15 Cobe Laboratories, Inc. Extracorporeal fluid treatment systems selectively operable in a treatment mode or a disinfecting mode
DE19630826A1 (de) * 1996-07-31 1998-02-05 Duro Galvanit Chemie Verfahren zur Aufbereitung von Chlor und gegebenenfalls chlororganische Verbindung enthaltendem Rohwasser, insbesondere Badwasser, sowie Vorrichtung zur Durchführung des vorgenannten Verfahrens
FI103106B (fi) * 1997-11-12 1999-04-30 Steris Europe Inc Menetelmä ja laite puhtaan veden tuottamiseksi
US6555055B1 (en) * 1998-07-29 2003-04-29 Lynntech, Inc. System for preventing and remediating biofilms in dental equipment
SE9903331D0 (sv) 1999-09-16 1999-09-16 Gambro Lundia Ab Method and apparatus for sterilising a heat sensitive fluid
US6527738B1 (en) 1999-04-30 2003-03-04 Prismedical Corporation Drug delivery pack
US20040215129A1 (en) * 1999-09-16 2004-10-28 Gambro Ab Method and cycler for the administration of a peritoneal dialysis fluid
US6428505B1 (en) * 1999-11-19 2002-08-06 Prismedical Corporation In-line IV drug delivery pack with controllable dilution
US6585890B2 (en) * 2000-02-04 2003-07-01 Applied Research Associates, Inc. Process for producing sterile water for injection from potable water
US6817541B2 (en) 2000-09-01 2004-11-16 Del Industries, Inc. Ozone systems and methods for agricultural applications
CA2448696A1 (fr) 2001-05-04 2002-11-14 Prismedical Corporation Conteneur de dissolution a deux chambres a agitation passive
US7250619B2 (en) * 2001-05-14 2007-07-31 Prismedical Corporation Powered sterile solution device
US6649063B2 (en) * 2001-07-12 2003-11-18 Nxstage Medical, Inc. Method for performing renal replacement therapy including producing sterile replacement fluid in a renal replacement therapy unit
AU2002341671A1 (en) * 2001-09-14 2003-04-01 Cornell Research Foundation, Inc. System, method and apparatus for small pulmonary nodule computer aided diagnosis from computed tomography scans
US7572359B2 (en) * 2001-10-15 2009-08-11 Siemens Water Technologies Holding Corp. Apparatus for fluid purification and methods of manufacture and use thereof
US6983721B2 (en) * 2001-10-19 2006-01-10 Hydropac/Lab Products, Inc. Method and system of providing sealed bags of fluid at the clean side of a laboratory facility
WO2003040042A1 (fr) * 2001-11-05 2003-05-15 Bionomics Ltd. Appareil et procede de production d'eau purifiee a haute purete microbiologique utilisant un ensemble membrane a osmose inverse
GB0205893D0 (en) * 2002-03-13 2002-04-24 Otv Sa Water purification apparatus
US7122149B2 (en) * 2002-07-12 2006-10-17 Applied Research Associates, Inc. Apparatus and method for continuous depyrogenation and production of sterile water for injection
AU2003249296A1 (en) 2002-07-19 2004-02-09 Baxter Healthcare S.A. Systems and methods for performing peritoneal dialysis
DE602004021672D1 (de) 2003-01-07 2009-08-06 Nxstage Medical Inc Chargenfiltriersystem zur herstellung einer sterilen ersatzflüssigkeit für nierenbehandlungen
US9700663B2 (en) 2005-01-07 2017-07-11 Nxstage Medical, Inc. Filtration system for preparation of fluids for medical applications
US20080210606A1 (en) * 2004-01-07 2008-09-04 Jeffrey Burbank Filtration System Preparation of Fluids for Medical Applications
US6977047B2 (en) 2003-09-15 2005-12-20 Mechanical Equipment Company, Inc. Method and system for the manufacture of pharmaceutical water
WO2005046439A2 (fr) 2003-11-07 2005-05-26 Nxstage Medical, Inc. Procedes et appareil ameliores permettant de detecter les fuites dans des systemes de traitement sanguin
US20050103717A1 (en) 2003-11-13 2005-05-19 United States Filter Corporation Water treatment system and method
US7083733B2 (en) * 2003-11-13 2006-08-01 Usfilter Corporation Water treatment system and method
US8377279B2 (en) 2003-11-13 2013-02-19 Siemens Industry, Inc. Water treatment system and method
US7744553B2 (en) 2003-12-16 2010-06-29 Baxter International Inc. Medical fluid therapy flow control systems and methods
EP1748835B1 (fr) * 2004-05-13 2012-05-02 Nouveau, Inc. Methode de produire une boisson de residus de distillation de produits de fermentation
US7329358B2 (en) 2004-05-27 2008-02-12 Siemens Water Technologies Holding Corp. Water treatment process
US7396453B1 (en) * 2005-04-19 2008-07-08 Procorp Enterprises, Llc Hydraulically integrated solids/liquid separation system for wastewater treatment
AU2006245567A1 (en) * 2005-05-06 2006-11-16 Imi Vision Limited Dialysis machine
US7569146B2 (en) * 2005-05-12 2009-08-04 Nouveau Inc. By-products from fermentation still bottoms
EP1885655B1 (fr) 2005-06-01 2014-12-17 Evoqua Water Technologies LLC Procédé de traitement de l'eau par une désinfection intermittente
WO2007045015A1 (fr) * 2005-10-20 2007-04-26 Osmoflo Pty Ltd Systeme de production et de distribution d'eau purifiee
US20070102357A1 (en) * 2005-11-09 2007-05-10 David Weatherill Heat sanitization for reverse osmosis systems
CA2527287A1 (fr) * 2005-11-17 2007-05-17 Alberta Research Council Inc. Systeme de mise a zero et de referencement automatiques de mesure lumineuse
MX2009000961A (es) * 2006-07-25 2009-02-20 Nestec Sa Dispensador para preparar una composicion nutricional.
US7744760B2 (en) 2006-09-20 2010-06-29 Siemens Water Technologies Corp. Method and apparatus for desalination
WO2008048656A2 (fr) * 2006-10-18 2008-04-24 Kinetico Incorporated Appareil d'électrorégénération et procédé de traitement d'eau
US20080105620A1 (en) * 2006-11-06 2008-05-08 Hicks Lawrence A Water purification system
JP5313230B2 (ja) 2007-04-16 2013-10-09 コーニンクレッカ フィリップス エヌ ヴェ 飲料を生成するための装置及びその装置の使用
US8562908B2 (en) * 2007-06-29 2013-10-22 Baxter International Inc. Devices, systems, and methods for cleaning, disinfecting, rinsing, and priming blood separation devices and associated fluid lines
US7736328B2 (en) 2007-07-05 2010-06-15 Baxter International Inc. Dialysis system having supply container autoconnection
US7892423B2 (en) 2008-02-14 2011-02-22 Baxter International Inc. Dialysis system including multi-heater power coordination
US10973968B2 (en) 2008-02-14 2021-04-13 Baxter International Inc. Control of a water device via a dialysis machine user interface
US8518252B1 (en) 2008-05-12 2013-08-27 Applied Research Associates, Inc. System for field intravenous fluid reconstruction
US8153006B1 (en) 2008-06-05 2012-04-10 Procorp Enterprises, Llc Anaerobic treatment process for ethanol production
US8057679B2 (en) 2008-07-09 2011-11-15 Baxter International Inc. Dialysis system having trending and alert generation
DE102009037917B4 (de) * 2009-08-19 2016-04-07 Fresenius Medical Care Deutschland Gmbh Schlauchset für eine Vorrichtung zur Blutbehandlung und Vorrichtung zur Blutbehandlung mit einem Schlauchset
US9045352B2 (en) 2010-08-20 2015-06-02 Stryker Corporation Total fluid management system
US8951219B2 (en) 2011-04-29 2015-02-10 Medtronic, Inc. Fluid volume monitoring for patients with renal disease
DE102011109093A1 (de) * 2011-08-01 2013-02-07 Manfred Völker Kombination eines Einzelplatz-RO-Gerätes mit einem Hämodialysegerät
US20130146541A1 (en) 2011-12-13 2013-06-13 Nxstage Medical, Inc. Fluid purification methods, devices, and systems
US9724645B2 (en) 2012-02-02 2017-08-08 Tangent Company Llc Electrochemically regenerated water deionization
US10010663B2 (en) 2013-02-01 2018-07-03 Medtronic, Inc. Fluid circuit for delivery of renal replacement therapies
US9623164B2 (en) 2013-02-01 2017-04-18 Medtronic, Inc. Systems and methods for multifunctional volumetric fluid control
US10850016B2 (en) 2013-02-01 2020-12-01 Medtronic, Inc. Modular fluid therapy system having jumpered flow paths and systems and methods for cleaning and disinfection
GB201305755D0 (en) 2013-03-28 2013-05-15 Quanta Fluid Solutions Ltd Re-Use of a Hemodialysis Cartridge
WO2015066731A2 (fr) 2013-11-04 2015-05-07 Medtronic, Inc. Procédé et dispositif pour gérer des volumes de fluides dans le corps
GB201409796D0 (en) 2014-06-02 2014-07-16 Quanta Fluid Solutions Ltd Method of heat sanitization of a haemodialysis water circuit using a calculated dose
US10098993B2 (en) 2014-12-10 2018-10-16 Medtronic, Inc. Sensing and storage system for fluid balance
US10874787B2 (en) 2014-12-10 2020-12-29 Medtronic, Inc. Degassing system for dialysis
US9713665B2 (en) 2014-12-10 2017-07-25 Medtronic, Inc. Degassing system for dialysis
KR20180036644A (ko) 2015-03-13 2018-04-09 더 클리블랜드 클리닉 파운데이션 멸균 및/또는 정제된 유체 및/또는 용액 전달 시스템
JP2018524718A (ja) 2015-06-25 2018-08-30 ガンブロ・ルンディア・エービーGambro Lundia Ab 分散データベースを有する医療装置システム及び方法
US10980930B2 (en) 2015-07-24 2021-04-20 Medtronic, Inc Fluid connectors and fluid flow paths for an infusate caddy
ES2942732T3 (es) 2015-07-24 2023-06-06 Medtronic Inc Carrito de fluido de infusión para diálisis
US11103626B2 (en) * 2015-07-24 2021-08-31 Medtronic, Inc. Infusate holder
US10888648B2 (en) 2015-07-24 2021-01-12 Medtronic, Inc Dialysis priming steps using an infusate caddy
GB2543801A (en) 2015-10-28 2017-05-03 Quanta Fluid Solutions Ltd Dialysis machine and ultrafiltration
GB201523104D0 (en) 2015-12-30 2016-02-10 Quanta Fluid Solutions Ltd Dialysis machine
US10874790B2 (en) 2016-08-10 2020-12-29 Medtronic, Inc. Peritoneal dialysis intracycle osmotic agent adjustment
US10994064B2 (en) 2016-08-10 2021-05-04 Medtronic, Inc. Peritoneal dialysate flow path sensing
CN108778362A (zh) * 2016-04-04 2018-11-09 美敦力公司 具有集成循环仪的腹膜透析液产生系统
JP6925362B2 (ja) * 2016-04-04 2021-08-25 メドトロニック,インコーポレイテッド 腹膜透析液流体生成システム
JP6936250B2 (ja) 2016-05-06 2021-09-15 ガンブロ ルンディア アー・ベー 使用場所での透析流体調製を有し、かつその試験を含む腹膜透析のためのシステムおよび方法
CN105903402A (zh) * 2016-05-26 2016-08-31 江苏通协机械设备有限公司 一种血透剂配液集中供应系统
US10744253B2 (en) 2016-08-10 2020-08-18 Medtronic, Inc. Adaptive peritoneal dialysis intra-session adjustments for overall session optimization
US10537673B2 (en) 2016-08-10 2020-01-21 Medtronic, Inc. Intersession adaptive peritoneal dialysis fluid removal for multiple session optimization
US10758659B2 (en) 2016-08-10 2020-09-01 Medtronic, Inc. Peritoneal dialysis filtrate sampling and adaptive prescription
US11013843B2 (en) 2016-09-09 2021-05-25 Medtronic, Inc. Peritoneal dialysis fluid testing system
JP7153017B2 (ja) 2016-12-21 2022-10-13 ガンブロ・ルンディア・エービー 外部ドメインをサポートするセキュアクラスタドメインを有する情報技術インフラストラクチャを含む医療機器システム
GB201622119D0 (en) 2016-12-23 2017-02-08 Quanta Dialysis Tech Ltd Improved valve leak detection system
GB201703048D0 (en) 2017-02-24 2017-04-12 Quanta Dialysis Tech Ltd Testing rotor engagement of a rotary peristaltic pump
EP3618887A1 (fr) * 2017-05-05 2020-03-11 Gambro Lundia AB Système et méthode de production de fluide contrôlé microbiologiquement
US10493192B2 (en) 2017-05-12 2019-12-03 Medtronic, Inc. Infusate sleeve
US10561779B2 (en) 2017-05-12 2020-02-18 Medtronic, Inc. Infusate containers
USD907211S1 (en) 2017-09-28 2021-01-05 Quanta Dialysis Technologies Ltd. Dialysis machine
US11278654B2 (en) 2017-12-07 2022-03-22 Medtronic, Inc. Pneumatic manifold for a dialysis system
US11033667B2 (en) 2018-02-02 2021-06-15 Medtronic, Inc. Sorbent manifold for a dialysis system
US11110215B2 (en) 2018-02-23 2021-09-07 Medtronic, Inc. Degasser and vent manifolds for dialysis
US11806457B2 (en) 2018-11-16 2023-11-07 Mozarc Medical Us Llc Peritoneal dialysis adequacy meaurements
US11806456B2 (en) 2018-12-10 2023-11-07 Mozarc Medical Us Llc Precision peritoneal dialysis therapy based on dialysis adequacy measurements
US11850344B2 (en) 2021-08-11 2023-12-26 Mozarc Medical Us Llc Gas bubble sensor
US11944733B2 (en) 2021-11-18 2024-04-02 Mozarc Medical Us Llc Sodium and bicarbonate control

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3836458A (en) * 1971-09-27 1974-09-17 Carborundum Co Water purification means
FR2309238A1 (fr) * 1975-05-02 1976-11-26 Gow James Procede et appareil pour produire des solutions aqueuses a usage medical
GB2056314A (en) * 1979-08-13 1981-03-18 Vaponics Purification of water involving ultrafiltration
EP0056855A2 (fr) * 1980-12-02 1982-08-04 Tracor, Inc. Préparation d'une eau utilisable pour perfusions
EP0152051A2 (fr) * 1984-02-10 1985-08-21 Millipore Corporation Procédé et installation pour produire des solutions aqueuses et de l'eau stériles
US4808287A (en) * 1987-12-21 1989-02-28 Hark Ernst F Water purification process

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3836458A (en) * 1971-09-27 1974-09-17 Carborundum Co Water purification means
FR2309238A1 (fr) * 1975-05-02 1976-11-26 Gow James Procede et appareil pour produire des solutions aqueuses a usage medical
GB2056314A (en) * 1979-08-13 1981-03-18 Vaponics Purification of water involving ultrafiltration
EP0056855A2 (fr) * 1980-12-02 1982-08-04 Tracor, Inc. Préparation d'une eau utilisable pour perfusions
EP0152051A2 (fr) * 1984-02-10 1985-08-21 Millipore Corporation Procédé et installation pour produire des solutions aqueuses et de l'eau stériles
US4808287A (en) * 1987-12-21 1989-02-28 Hark Ernst F Water purification process

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0970919A1 (fr) * 1998-07-08 2000-01-12 Klaus Dr. Leiter Dispositif pour la désinfection d'une unité de traitement d'eau
WO2000057926A1 (fr) * 1999-03-30 2000-10-05 Hospal Industrie Procede et dispositif pour steriliser et dispenser un liquide a usage medical
WO2000057925A1 (fr) * 1999-03-30 2000-10-05 Hospal Industrie Procede et dispositif pour steriliser et dispenser un liquide a usage medical
WO2000057927A1 (fr) * 1999-03-30 2000-10-05 Hospal Industrie Procede et dispositif pour steriliser et dispenser un liquide a usage medical
FR2791576A1 (fr) * 1999-03-30 2000-10-06 Hospal Ind Procede et dispositif pour steriliser et dispenser un liquide a usage medical
FR2791575A1 (fr) * 1999-03-30 2000-10-06 Hospal Ind Procede et dispositif pour steriliser et dispenser un liquide a usage medical
FR2791574A1 (fr) * 1999-03-30 2000-10-06 Hospal Ind Procede et dispositif pour steriliser et dispenser un liquide a usage medical
US6579494B1 (en) 1999-03-30 2003-06-17 Hospal Industrie Process and device for sterilizing and dispensing a liquid for medical use
FR2845605A1 (fr) * 2002-10-15 2004-04-16 Gambro Lundia Ab Procede et dispositif pour la preparation en ligne de liquide pour un appareil destine au traitement extracorporel du sang
EP1410813A1 (fr) * 2002-10-15 2004-04-21 Gambro Lundia AB Procédé et dispositif pour la préparation en ligne de liquide pour un appareil destiné au traitement extracorporel du sang
WO2004037726A1 (fr) * 2002-10-23 2004-05-06 Usfilter Corporation Production d'eau pour injection par osmose inverse
ES2237242A1 (es) * 2002-10-29 2005-07-16 Jesus Manuel Taboada Presedo Sistema de tratamiento de agua para hemodialisis.
US9023185B2 (en) 2006-06-22 2015-05-05 Evoqua Water Technologies Llc Low scale potential water treatment
US9586842B2 (en) 2006-06-22 2017-03-07 Evoqua Water Technologies Llc Low scale potential water treatment
US8585882B2 (en) 2007-11-30 2013-11-19 Siemens Water Technologies Llc Systems and methods for water treatment
US9011660B2 (en) 2007-11-30 2015-04-21 Evoqua Water Technologies Llc Systems and methods for water treatment
US9637400B2 (en) 2007-11-30 2017-05-02 Evoqua Water Technologies Llc Systems and methods for water treatment

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DE69113129D1 (de) 1995-10-26
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US5032265A (en) 1991-07-16

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